Electronic Informed Consent

Consent participants on any device. In minutes.

Capture.Study eConsent lets participants read, understand, and sign informed consent forms on their phone, tablet, or computer. Multi-party signatures, witness co-signing, investigator countersignature. 21 CFR Part 11 compliant. Try it free.

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No credit cardNo paper, no scanningSetup in under 10 minutes
100%
Digital workflow
$19
Per patient / month
0
Paper forms to file
21 CFR Part 11 electronic signaturesICH-GCP E6(R2) compliantWorks on any deviceHIPAA and GDPR ready

What is eConsent software?

Electronic Informed Consent (eConsent) software replaces paper consent forms with a digital workflow. Participants read the consent document on their own device, ask questions, and sign electronically. The entire process is captured with a tamper-proof audit trail.

Good eConsent software eliminates the logistical burden of printing, signing, scanning, and filing paper forms. It reduces consent errors, speeds up enrollment, and gives monitors instant access to signed documents. Capture.Study provides all of this and lets you try it for free before you commit.

If this sounds familiar, you need eConsent.

Paper consent creates delays, errors, and compliance risk. Here is what changes when you go digital.

Paper Consent

With Capture eConsent

Print forms, sign in person, scan, file
Participant reads and signs on their phone or tablet
Missing signatures discovered weeks later
Real-time status: signed, pending, or countersigned
No proof of what version was signed
Document hash links each signature to exact content
Monitors request consent binders at site visits
All signed documents accessible online, instantly
Re-consent requires reprinting and re-signing
Push new versions digitally, track who signed what

Ready to stop chasing paper signatures?

How It Works

From document to signed consent in one session.

No printing. No scanning. No filing cabinets.

1

Build your consent form

Use the consent form builder to create sections, add comprehension checks, and configure signature requirements. Support for witness co-signatures and LAR (Legally Authorized Representative) signing.

2

Participant reviews and signs

Participants receive a secure link. They read each section on their device, complete any required comprehension questions, and sign electronically. The document hash is recorded with their signature.

3

Investigator countersigns

The signed consent enters "pending countersignature" status. The investigator or authorized site staff reviews and countersigns with password re-authentication. The document is now fully executed.

eConsent Features

Everything you need for compliant informed consent.

Built for regulated clinical research. Every feature below is included in your subscription.

Multi-Party Signatures

Full signature workflow: participant signs, optional witness co-signs, then investigator countersigns. The document is only "Fully Executed" once all required parties have signed.

Sign on Any Device

Participants read and sign consent forms on their phone, tablet, or computer. No app download required. Works in any modern browser.

Investigator Countersignature

After participant submission, authorized site staff review and countersign with password re-authentication and a legal meaning statement. Full 21 CFR Part 11 compliance.

LAR and Witness Support

Support for Legally Authorized Representative (LAR) signatures when the participant cannot consent themselves. Optional witness co-signature for impartial third-party verification.

Document Hashing

Each signature is cryptographically linked to the exact document content. If the document changes, the hash changes. You can always prove what version was signed.

Comprehension Checks

Add questions between consent sections to verify participants understand key information before signing. Required by many IRBs and ethics committees.

Multi-Language Support

Create consent forms in multiple languages linked to the same study. Each participant sees the form in their language. All versions tracked separately.

Version Control

When your protocol changes, create a new consent version. Track which participants signed which version. Push re-consent to affected participants digitally.

Real-Time Status Dashboard

See consent status for every participant: not started, signed, pending countersignature, fully executed. Filter by site, date, or status.

Automated Reminders

Send reminders to participants who have not yet signed and to investigators with pending countersignatures. Configurable schedules and escalation rules.

PDF Export

Download signed consent documents as PDFs with embedded signature data, timestamps, and audit trail. Ready for your regulatory binder.

Integrated with EDC

Consent data lives alongside your CRF and ePRO data. One participant record, one audit trail. Consent status gates downstream study activities automatically.

All features included. No modules to buy separately.

Every signature meets regulatory standards.

Electronic signatures are verified through a two-step process: capture plus mandatory email OTP. Signers must acknowledge the legal binding status before signing. Data residency in EU (Frankfurt) and USA (N. Virginia).

21 CFR Part 11
ICH-GCP E6(R2)
GDPR
HIPAA

Tamper-proof audit trail on every consent

Every action is logged: when the participant opened the document, how long they spent on each section, when they signed, and when the investigator countersigned. Document hash, device fingerprint, IP address, and browser are all recorded. No configuration needed.

Why Capture

What makes Capture.Study eConsent different.

Full multi-party signature workflow.

Participant signs. Witness co-signs if required. Investigator countersigns with password re-authentication. The document is only marked "Fully Executed" when all required signatures are collected. This matches industry-standard workflows used by Medidata and Veeva.

Signatures are cryptographically linked to content.

Every signature records a hash of the exact document content at the time of signing. If even one character changes, the hash changes. You always have proof of what was signed.

No app download. No special hardware.

Participants open a secure link on their own phone, tablet, or computer. They read the document, answer comprehension questions, and sign. No app store, no provisioned devices.

eConsent and EDC in one platform.

Consent status automatically gates downstream study activities. If a participant has not signed, they cannot be enrolled. One system, one audit trail, one data export.

You can test the entire workflow for free.

Build your consent form, test the signing experience yourself, review the audit trail, and export the signed document. All free, no time limit. You only pay when you go live.

Questions we hear a lot.

Start consenting participants digitally today.

Build your consent form, test the signing workflow, and see the audit trail for yourself.

No credit card. No sales call. No commitment.

Request a Demo